Translational biomarkers

From preclinical to clinical a report of 2009 AAPS/ACCP biomarker workshop

Jane P.F. Bai, Robert Bell, Shaavhree Buckman, Gilbert J. Burckart, Hans Georg Eichler, Kenneth C. Fang, Federico M. Goodsaid, William J. Jusko, Lawrence L. Lesko, Bernd Meibohm, Scott D. Patterson, Oscar Puig, Jeffrey B. Smerage, Barbara J. Snider, John A. Wagner, Jingsong Wang, Marc K. Walton, Russell Weiner

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

There have been some successes in qualifying biomarkers and applying them to drug development and clinical treatment of various diseases. A recent success is illustrated by a collaborative effort among the US Food and Drug Administration, the European Medicines Agency, and the pharmaceutical industry to provide a set of seven preclinical kidney toxicity biomarkers for drug development. Other successes include, but are not limited to, clinical biomarkers for cancer treatment and clinical management of heart transplant patients. The value of fully qualified surrogate endpoints in facilitating successful drug development is undisputed, especially for diseases in which the traditional clinical outcome can only be assessed in large, multi-year trials. Emerging biomarkers, including chemical genomic or imaging biomarkers, and measurement of circulating tumor cells hold great promise for early diagnosis of disease and as prognostic tests for managing treatment of chronic diseases such as osteoarthritis, Alzheimer disease, cardiovascular disease, and cancer. To advance the success of treating and managing these diseases, efforts are needed to establish the temporal relationship between changes in inflammatory or imaging biomarkers with the progression of the chronic disease, and in the case of cancer, between the extent of circulating cancer cells and tumor progression or remission.

Original languageEnglish (US)
Pages (from-to)274-283
Number of pages10
JournalAAPS Journal
Volume13
Issue number2
DOIs
StatePublished - Jan 1 2011

Fingerprint

Biomarkers
Education
Circulating Neoplastic Cells
Chronic Disease
Neoplasms
Drug Industry
United States Food and Drug Administration
Tumor Biomarkers
Drug-Related Side Effects and Adverse Reactions
Osteoarthritis
Pharmaceutical Preparations
Early Diagnosis
Alzheimer Disease
Cardiovascular Diseases
Therapeutics
Transplants
Kidney

All Science Journal Classification (ASJC) codes

  • Pharmaceutical Science

Cite this

Bai, J. P. F., Bell, R., Buckman, S., Burckart, G. J., Eichler, H. G., Fang, K. C., ... Weiner, R. (2011). Translational biomarkers: From preclinical to clinical a report of 2009 AAPS/ACCP biomarker workshop. AAPS Journal, 13(2), 274-283. https://doi.org/10.1208/s12248-011-9265-x

Translational biomarkers : From preclinical to clinical a report of 2009 AAPS/ACCP biomarker workshop. / Bai, Jane P.F.; Bell, Robert; Buckman, Shaavhree; Burckart, Gilbert J.; Eichler, Hans Georg; Fang, Kenneth C.; Goodsaid, Federico M.; Jusko, William J.; Lesko, Lawrence L.; Meibohm, Bernd; Patterson, Scott D.; Puig, Oscar; Smerage, Jeffrey B.; Snider, Barbara J.; Wagner, John A.; Wang, Jingsong; Walton, Marc K.; Weiner, Russell.

In: AAPS Journal, Vol. 13, No. 2, 01.01.2011, p. 274-283.

Research output: Contribution to journalArticle

Bai, JPF, Bell, R, Buckman, S, Burckart, GJ, Eichler, HG, Fang, KC, Goodsaid, FM, Jusko, WJ, Lesko, LL, Meibohm, B, Patterson, SD, Puig, O, Smerage, JB, Snider, BJ, Wagner, JA, Wang, J, Walton, MK & Weiner, R 2011, 'Translational biomarkers: From preclinical to clinical a report of 2009 AAPS/ACCP biomarker workshop', AAPS Journal, vol. 13, no. 2, pp. 274-283. https://doi.org/10.1208/s12248-011-9265-x
Bai, Jane P.F. ; Bell, Robert ; Buckman, Shaavhree ; Burckart, Gilbert J. ; Eichler, Hans Georg ; Fang, Kenneth C. ; Goodsaid, Federico M. ; Jusko, William J. ; Lesko, Lawrence L. ; Meibohm, Bernd ; Patterson, Scott D. ; Puig, Oscar ; Smerage, Jeffrey B. ; Snider, Barbara J. ; Wagner, John A. ; Wang, Jingsong ; Walton, Marc K. ; Weiner, Russell. / Translational biomarkers : From preclinical to clinical a report of 2009 AAPS/ACCP biomarker workshop. In: AAPS Journal. 2011 ; Vol. 13, No. 2. pp. 274-283.
@article{5673d1bc026943f390df381f6435fc96,
title = "Translational biomarkers: From preclinical to clinical a report of 2009 AAPS/ACCP biomarker workshop",
abstract = "There have been some successes in qualifying biomarkers and applying them to drug development and clinical treatment of various diseases. A recent success is illustrated by a collaborative effort among the US Food and Drug Administration, the European Medicines Agency, and the pharmaceutical industry to provide a set of seven preclinical kidney toxicity biomarkers for drug development. Other successes include, but are not limited to, clinical biomarkers for cancer treatment and clinical management of heart transplant patients. The value of fully qualified surrogate endpoints in facilitating successful drug development is undisputed, especially for diseases in which the traditional clinical outcome can only be assessed in large, multi-year trials. Emerging biomarkers, including chemical genomic or imaging biomarkers, and measurement of circulating tumor cells hold great promise for early diagnosis of disease and as prognostic tests for managing treatment of chronic diseases such as osteoarthritis, Alzheimer disease, cardiovascular disease, and cancer. To advance the success of treating and managing these diseases, efforts are needed to establish the temporal relationship between changes in inflammatory or imaging biomarkers with the progression of the chronic disease, and in the case of cancer, between the extent of circulating cancer cells and tumor progression or remission.",
author = "Bai, {Jane P.F.} and Robert Bell and Shaavhree Buckman and Burckart, {Gilbert J.} and Eichler, {Hans Georg} and Fang, {Kenneth C.} and Goodsaid, {Federico M.} and Jusko, {William J.} and Lesko, {Lawrence L.} and Bernd Meibohm and Patterson, {Scott D.} and Oscar Puig and Smerage, {Jeffrey B.} and Snider, {Barbara J.} and Wagner, {John A.} and Jingsong Wang and Walton, {Marc K.} and Russell Weiner",
year = "2011",
month = "1",
day = "1",
doi = "10.1208/s12248-011-9265-x",
language = "English (US)",
volume = "13",
pages = "274--283",
journal = "AAPS Journal",
issn = "1550-7416",
publisher = "Springer New York",
number = "2",

}

TY - JOUR

T1 - Translational biomarkers

T2 - From preclinical to clinical a report of 2009 AAPS/ACCP biomarker workshop

AU - Bai, Jane P.F.

AU - Bell, Robert

AU - Buckman, Shaavhree

AU - Burckart, Gilbert J.

AU - Eichler, Hans Georg

AU - Fang, Kenneth C.

AU - Goodsaid, Federico M.

AU - Jusko, William J.

AU - Lesko, Lawrence L.

AU - Meibohm, Bernd

AU - Patterson, Scott D.

AU - Puig, Oscar

AU - Smerage, Jeffrey B.

AU - Snider, Barbara J.

AU - Wagner, John A.

AU - Wang, Jingsong

AU - Walton, Marc K.

AU - Weiner, Russell

PY - 2011/1/1

Y1 - 2011/1/1

N2 - There have been some successes in qualifying biomarkers and applying them to drug development and clinical treatment of various diseases. A recent success is illustrated by a collaborative effort among the US Food and Drug Administration, the European Medicines Agency, and the pharmaceutical industry to provide a set of seven preclinical kidney toxicity biomarkers for drug development. Other successes include, but are not limited to, clinical biomarkers for cancer treatment and clinical management of heart transplant patients. The value of fully qualified surrogate endpoints in facilitating successful drug development is undisputed, especially for diseases in which the traditional clinical outcome can only be assessed in large, multi-year trials. Emerging biomarkers, including chemical genomic or imaging biomarkers, and measurement of circulating tumor cells hold great promise for early diagnosis of disease and as prognostic tests for managing treatment of chronic diseases such as osteoarthritis, Alzheimer disease, cardiovascular disease, and cancer. To advance the success of treating and managing these diseases, efforts are needed to establish the temporal relationship between changes in inflammatory or imaging biomarkers with the progression of the chronic disease, and in the case of cancer, between the extent of circulating cancer cells and tumor progression or remission.

AB - There have been some successes in qualifying biomarkers and applying them to drug development and clinical treatment of various diseases. A recent success is illustrated by a collaborative effort among the US Food and Drug Administration, the European Medicines Agency, and the pharmaceutical industry to provide a set of seven preclinical kidney toxicity biomarkers for drug development. Other successes include, but are not limited to, clinical biomarkers for cancer treatment and clinical management of heart transplant patients. The value of fully qualified surrogate endpoints in facilitating successful drug development is undisputed, especially for diseases in which the traditional clinical outcome can only be assessed in large, multi-year trials. Emerging biomarkers, including chemical genomic or imaging biomarkers, and measurement of circulating tumor cells hold great promise for early diagnosis of disease and as prognostic tests for managing treatment of chronic diseases such as osteoarthritis, Alzheimer disease, cardiovascular disease, and cancer. To advance the success of treating and managing these diseases, efforts are needed to establish the temporal relationship between changes in inflammatory or imaging biomarkers with the progression of the chronic disease, and in the case of cancer, between the extent of circulating cancer cells and tumor progression or remission.

UR - http://www.scopus.com/inward/record.url?scp=79957455406&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79957455406&partnerID=8YFLogxK

U2 - 10.1208/s12248-011-9265-x

DO - 10.1208/s12248-011-9265-x

M3 - Article

VL - 13

SP - 274

EP - 283

JO - AAPS Journal

JF - AAPS Journal

SN - 1550-7416

IS - 2

ER -